ID

29216

Beskrivning

Comparison of Insulin Detemir and Insulin Aspart in 2 Separate Injections Twice Daily to Extemporaneous Mixing Injection Regimen Twice Daily - The Paediatric Mixing Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00542620

Länk

https://clinicaltrials.gov/show/NCT00542620

Nyckelord

Versioner (1)
  1. 2018-03-08 2018-03-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 mars 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes NCT00542620

Engelsk

Eligibility Diabetes NCT00542620

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00542620
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
parents' informed consent (ic) obtained before any trial-related activities
Beskrivning

Informed Consent Parent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
obtained child's assent (when possible)
Beskrivning

Informed Consent Child

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0008059
type 1 diabetes
Beskrivning

Diabetes Mellitus, Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
treatment with insulin detemir and insulin aspart either in extemporaneous mixed or separate injections
Beskrivning

Insulin detemir | Insulin Aspart | Injection Mixed | Injection Separate

Datatyp

boolean

Alias
UMLS CUI [1]
C0537270
UMLS CUI [2]
C1708521
UMLS CUI [3,1]
C1533685
UMLS CUI [3,2]
C0205430
UMLS CUI [4,1]
C1533685
UMLS CUI [4,2]
C0443299
hba1c (glycosylated haemoglobin a1c) lesser than or equal to 8.6%
Beskrivning

Glucohemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202054
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol
Beskrivning

Chronic Alcoholic Intoxication Informed Consent Invalid | Drug abuse Informed Consent Invalid | Mental disorders Informed Consent Invalid | Personality Disorders Informed Consent Invalid | Chronic Alcoholic Intoxication Preventing Protocol Compliance | Drug abuse Preventing Protocol Compliance | Mental disorders Preventing Protocol Compliance | Personality Disorders Preventing Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001973
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C1547465
UMLS CUI [2,1]
C0013146
UMLS CUI [2,2]
C0021430
UMLS CUI [2,3]
C1547465
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0021430
UMLS CUI [3,3]
C1547465
UMLS CUI [4,1]
C0031212
UMLS CUI [4,2]
C0021430
UMLS CUI [4,3]
C1547465
UMLS CUI [5,1]
C0001973
UMLS CUI [5,2]
C1292733
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C0013146
UMLS CUI [6,2]
C1292733
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C1292733
UMLS CUI [7,3]
C0525058
UMLS CUI [8,1]
C0031212
UMLS CUI [8,2]
C1292733
UMLS CUI [8,3]
C0525058
mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation
Beskrivning

Mental handicap Excludes Comprehension Study Protocol | Comprehension Study Protocol Unwilling | Language problems Exclude Comprehension Study Protocol | Mental handicap Excludes Compliance behavior | Compliance behavior Unwilling | Language problems Exclude Compliance behavior

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1306341
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C2348563
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C1405458
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0162340
UMLS CUI [3,4]
C2348563
UMLS CUI [4,1]
C1306341
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C1321605
UMLS CUI [5,1]
C1321605
UMLS CUI [5,2]
C0558080
UMLS CUI [6,1]
C1405458
UMLS CUI [6,2]
C0332196
UMLS CUI [6,3]
C1321605
anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)
Beskrivning

Change of medication Interferes with Glucose metabolism | Pharmaceutical Preparations New Interfere with Glucose metabolism | Adrenal Cortex Hormones Systemic U/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0580105
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0596620
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0205314
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0596620
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C0205373
UMLS CUI [3,3]
C0456683
any other condition that the investigator (trial physician) feels would interfere with trial participation or evaluation of results
Beskrivning

Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
UMLS CUI [2,4]
C0683954
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Similar models

Eligibility Diabetes NCT00542620

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00542620
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent Parent
Item
parents' informed consent (ic) obtained before any trial-related activities
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
Informed Consent Child
Item
obtained child's assent (when possible)
boolean
C0021430 (UMLS CUI [1,1])
C0008059 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Insulin detemir | Insulin Aspart | Injection Mixed | Injection Separate
Item
treatment with insulin detemir and insulin aspart either in extemporaneous mixed or separate injections
boolean
C0537270 (UMLS CUI [1])
C1708521 (UMLS CUI [2])
C1533685 (UMLS CUI [3,1])
C0205430 (UMLS CUI [3,2])
C1533685 (UMLS CUI [4,1])
C0443299 (UMLS CUI [4,2])
Glucohemoglobin measurement
Item
hba1c (glycosylated haemoglobin a1c) lesser than or equal to 8.6%
boolean
C0202054 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chronic Alcoholic Intoxication Informed Consent Invalid | Drug abuse Informed Consent Invalid | Mental disorders Informed Consent Invalid | Personality Disorders Informed Consent Invalid | Chronic Alcoholic Intoxication Preventing Protocol Compliance | Drug abuse Preventing Protocol Compliance | Mental disorders Preventing Protocol Compliance | Personality Disorders Preventing Protocol Compliance
Item
history of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol
boolean
C0001973 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1547465 (UMLS CUI [1,3])
C0013146 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
C1547465 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0021430 (UMLS CUI [3,2])
C1547465 (UMLS CUI [3,3])
C0031212 (UMLS CUI [4,1])
C0021430 (UMLS CUI [4,2])
C1547465 (UMLS CUI [4,3])
C0001973 (UMLS CUI [5,1])
C1292733 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0013146 (UMLS CUI [6,1])
C1292733 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0004936 (UMLS CUI [7,1])
C1292733 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C0031212 (UMLS CUI [8,1])
C1292733 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])
Mental handicap Excludes Comprehension Study Protocol | Comprehension Study Protocol Unwilling | Language problems Exclude Comprehension Study Protocol | Mental handicap Excludes Compliance behavior | Compliance behavior Unwilling | Language problems Exclude Compliance behavior
Item
mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation
boolean
C1306341 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0162340 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C1405458 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0162340 (UMLS CUI [3,3])
C2348563 (UMLS CUI [3,4])
C1306341 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C1321605 (UMLS CUI [4,3])
C1321605 (UMLS CUI [5,1])
C0558080 (UMLS CUI [5,2])
C1405458 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C1321605 (UMLS CUI [6,3])
Change of medication Interferes with Glucose metabolism | Pharmaceutical Preparations New Interfere with Glucose metabolism | Adrenal Cortex Hormones Systemic U/day
Item
anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)
boolean
C0580105 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0596620 (UMLS CUI [2,4])
C0001617 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0456683 (UMLS CUI [3,3])
Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results
Item
any other condition that the investigator (trial physician) feels would interfere with trial participation or evaluation of results
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
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